Idecabtagene vicleucel

Idecabtagene vicleucel (Abecma, Bristol-Myers Squibb Pharma EEIG) has 1 EU-approved indication in 1 tumour type.

Approved indications of Idecabtagene vicleucel
Biomarker requirement	Regimen	Setting	Conditions

Multiple myeloma1
None	Monotherapy	3L+	After at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, with disease progression on the last therapy

Full text of section 4.1 (therapeutic indications)

Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Label history

15 changes to the Abecma label since 2021, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.